OCTREOTIDE DEPOT octreotide (as acetate) 10 mg modified release injection vial plus diluent prefilled syringe composite pack

Страна: Австралия

Язык: английский

Источник: Department of Health (Therapeutic Goods Administration)

Активный ингредиент:

octreotide, Quantity: 10 mg

Доступна с:

Teva Pharma Australia Pty Ltd

Фармацевтическая форма:

Injection, modified release

состав:

Excipient Ingredients: polyglactin; mannitol

Администрация маршрут:

Intramuscular

Штук в упаковке:

1 x 8 mL vial of powder with 1 x 3 mL pre-filled syringe of diluent

Тип рецепта:

(S4) Prescription Only Medicine

Терапевтические показания :

Acromegaly For the symptomatic control and reduction of growth hormone and IGF-1 plasma levels in patients with acromegaly, including those who are inadequately controlled by surgery, radiotherapy, or dopamine agonist treatment but who are adequately controlled on s.c. treatment with octreotide. Octreotide Depot is also indicated in acromegalic patients unfit or unwilling to undergo surgery, or in the interim period until radiotherapy becomes fully effective.,Gastro-entero-pancreatic tumours For the relief of symptoms associated with the following functional tumours of the gastro-enteropancreatic endocrine system: ? Carcinoid tumours with features of the carcinoid syndrome ? Vasoactive intestinal peptide secreting tumours (VIPomas) in patients who are adequately controlled on subcutaneous treatment with octreotide Octreotide Depot is not curative in these patients.,Advanced Neuroendocrine Tumours of the Midgut Treatment of patients with progression of well-differentiated, advanced neuroendocrine tumours of the midgut or suspected midgut origin.

Обзор продуктов:

Visual Identification: The powder is a white to white with yellowish tint.; Container Type: Multiple containers; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Статус Авторизация:

Registered

Дата Авторизация:

2020-11-25

тонкая брошюра

OCTREOTIDE DEPOT
®
_Octreotide (as acetate)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Octreotide Depot. It
does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Octreotide
Depot against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT OCTREOTIDE
DEPOT IS USED FOR
Octreotide Depot is a long acting
form of octreotide injection. It is
injected into the buttocks once every
4 weeks, instead of having frequent
injections of the octreotide under the
skin.
•
Octreotide Depot is used to treat
acromegaly
In people with acromegaly the body
makes too much growth hormone
which controls the growth of tissues,
organs and bones. Too much growth
hormone leads to enlargement of the
bones, especially of the hands and
feet. Other symptoms include
headaches, increased sweating,
tiredness, numbness of the hands and
feet, pain and stiffness in the joints
and loss of sexual function. By
blocking the excess growth hormone,
Octreotide Depot can relieve many of
these symptoms.
•
Octreotide Depot is used to
relieve symptoms of certain types
of cancer such as carcinoid
tumour and VIPoma.
By blocking hormones that are over-
produced in these conditions,
Octreotide Depot can relieve
symptoms such as flushing of the
skin and severe diarrhoea. Octreotide
Depot contains octreotide, a man-
made medicine derived from
somatostatin. Somatostatin is a
substance found in the human body
which controls the effects of certain
hormones such as insulin and growth
hormone. Octreotide Depot is used
instead of somatostatin because its
effects are stronger and last longer.
•
Octreotide Depot is used to treat
advanced neuroendocrine
tumours located in the gut (eg
appendix, small intestine or
colo

Характеристики продукта

Teva Pharma Australia Pty Limited
Version 2
1
AUSTRALIAN PRODUCT INFORMATION – OCTREOTIDE DEPOT
(OCTREOTIDE) MODIFIED RELEASE INJECTION
1
NAME OF THE MEDICINE
Octreotide.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
OCTREOTIDE DEPOT octreotide (as acetate) 10 mg modified release
injection plus diluent
OCTREOTIDE DEPOT octreotide (as acetate) 20 mg modified release
injection plus diluent
OCTREOTIDE DEPOT octreotide (as acetate) 30 mg modified release
injection plus diluent
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Modified release, injection
Octreotide Depot is a modified release injection of octreotide. The
octreotide is
distributed within polymer microspheres. The powder is a white to
white with yellowish
tint.
Diluent
The vehicle is a clear, colourless to slightly yellow or brown
solution. The pH of the
reconstituted suspension is 5-8.
Single glass vials of 10, 20 or 30 mg octreotide modified release
injection to be
suspended in 2 mL diluent prior to injection.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Acromegaly
For the symptomatic control and reduction of growth hormone and IGF-1
plasma levels in patients
with acromegaly, including those who are inadequately controlled by
surgery, radiotherapy, or
dopamine agonist treatment but who are adequately controlled on s.c.
treatment with octreotide.
Octreotide Depot is also indicated in acromegalic patients unfit or
unwilling to undergo surgery, or in
the interim period until radiotherapy becomes fully effective.
Gastro-entero-pancreatic tumours
For the relief of symptoms associated with the following functional
tumours of the gastro-entero-
pancreatic endocrine system:
•
Carcinoid tumours with features of the carcinoid syndrome
•
Vasoactive intestinal peptide secreting tumours (VIPomas) in patients
who are adequately
controlled on subcutaneous treatment with octreotide
Teva Pharma Australia Pty Limited
Version 2
2
Octreotide Depot is not curative in these patients.
Advanced Neuroendocrine Tumours of the